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2016-03-03

Novavax Reports Fourth Quarter and Year-End 2015 Financial Results

nd 2015 Financial Results

GAITHERSBURG, Md., 2016-02-29 13:31 CET (GLOBE NEWSWIRE) -- Novavax, Inc.,
(Nasdaq:NVAX) a clinical-stage vaccine company focused on the discovery,
development and commercialization of recombinant nanoparticle vaccines and
adjuvants, today announced its financial results for the fourth quarter and
twelve months ended December 31, 2015.

Recent Accomplishment:

-- Novavax issued a total of $325 million Convertible Senior Notes, resulting
in net proceeds of approximately $276 million. These proceeds further
strengthen Novavax’ balance sheet ahead of data from the pivotal Phase 3
Resolve™ clinical trial, expected in the third quarter of 2016, and in
support of discussions for the commercialization rights to its RSV F
Vaccine franchise outside North America, while minimizing dilution.

Novavax Fourth Quarter Achievements:

-- Completed target enrollment of the Resolve trial of its RSV F Vaccine in
older adults (60 years of age and older). Resolve is a randomized,
observer-blinded, placebo-controlled trial of 11,850 older adults at 60
sites in the United States. The primary efficacy objective is the
prevention of moderate-severe RSV-associated lower respiratory tract
disease, as defined by the presence of multiple lower respiratory tract
symptoms.
-- Completed enrollment of 1,330 older adults in a Phase 2 rollover clinical
trial of its RSV F Vaccine in older adults enrolled in the prior Phase 2
trial. The trial is a randomized, observer-blinded, placebo-controlled
rollover trial designed to enroll from the population of 1,600 older adults
who participated in the prior Phase 2 trial. The primary endpoints of the
trial will evaluate safety and serum anti-F IgG antibody concentrations in
response to immunization with the RSV F Vaccine.
-- Initiated enrollment in a global pivotal Phase 3 clinical trial, known as
Prepare™, of its RSV F Vaccine in healthy pregnant women. Prepare is a
randomized, observer-blinded, placebo-controlled trial that utilizes a
group sequential design, thus, the eventual sample size may vary between
5,000 and 8,255 pregnant women over a period of two to four years. The
primary objective is to determine the efficacy of maternal immunization
with the RSV F Vaccine against symptomatic RSV lower respiratory tract
infection (LRTI) with hypoxemia in infants through the first 90 days of
life. Novavax previously announced it was awarded a grant up to $89 million
from the Bill & Melinda Gates Foundation to support development of this
RSV F Vaccine for infants via maternal immunization.
-- Appointed Jeffrey Stoddard, M.D. to Vice President, Medical Affairs and
Mark Twyman to Vice President, Marketing and promoted Jody Lichaa to Vice
President, Quality Assurance.

2016 Anticipated Events:

-- Announce top-line data from Resolve, the Phase 3 pivotal RSV F Vaccine in
older adults in third quarter of 2016; and
-- Announce top-line data from the Phase 2 RSV F Vaccine rollover trial in
older adults in the second half of 2016.

Summary

“During the fourth quarter, we initiated two pivotal Phase 3 trials of our RSV
F Vaccine, and subsequently completed enrollment of our Resolve trial in older
adults. We expect to announce value-creating data from the Resolve trial and
the Phase 2 rollover trial in older adults in 2016,” said Stanley C. Erck,
President and CEO. “In addition, we recently strengthened our balance sheet
through the successful completion of a convertible note offering, providing the
necessary resources for the continued execution of our business plan.”

Financial Results for the Three and Twelve Months Ended December 31, 2015

Novavax reported a net loss of $78.8 million, or $0.29 per share, for the
fourth quarter of 2015, compared to a net loss of $31.5 million, or $0.13 per
share, for the fourth quarter of 2014. For the twelve months ended December 31,
2015, the net loss was $156.9 million, or $0.60 per share, compared to a net
loss of $82.9 million, or $0.37 per share, for the same period in 2014.

Novavax revenue in the fourth quarter of 2015 decreased 13% to $5.9 million,
compared to $6.7 million for the same period in 2014. Revenue for the full year
2015 increased 18% to $36.3 million, compared to $30.7 million in 2014. The
increase in full year revenue results from the recovery of additional costs
under the BARDA contract of $7.7 million for the settlement of indirect rates
for fiscal years 2011 and 2012 and $3.1 million relating to the Company’s prior
Phase 2 clinical trial of our quadrivalent seasonal influenza VLP vaccine
candidate in Australia as collection of the amount became reasonably assured in
2015. These increases in revenue were partially offset by a decrease in revenue
resulting from a lower level of development activities under the BARDA contract
and our prior PATH agreement, as compared to 2014.

We have historically recorded certain reimbursable research and development
costs incurred under our government contracts in a line item titled “Cost of
government contracts revenue.” Those costs are included in “Research and
development expenses” for all periods presented in this press release and in
the 2015 Annual Report on Form 10-K to be filed with the SEC.

Research and development expenses increased 128% to $75.9 million in the fourth
quarter of 2015, compared to $33.3 million for the same period in 2014. For the
full year 2015, research and development expenses increased 72% to $162.6
million, compared to $94.4 million in 2014. The increase in research and
development expenses for the full year 2015 was driven by costs related to the
initiation of our two pivotal Phase 3 clinical trials and Phase 2 rollover
trial of the RSV F Vaccine and higher employee-related costs, including
non-cash stock-based compensation, tied to the continued growth of the company.
This increase was partially offset by a lower level of development activities
under the BARDA contract.

General and administrative expenses increased 75% to $8.9 million in the fourth
quarter of 2015, compared to $5.1 million for the same period in 2014. For the
full year 2015, general and administrative expenses increased 55% to $30.8
million, compared to $19.9 million in 2014. The increase in general and
administrative expenses for the full year 2015 resulted from increased
employee-related expenses, including non-cash stock-based compensation, tied to
the continued growth of the company and professional fees for
pre-commercialization activities.

As of December 31, 2015, the company had $230.7 million in cash and cash
equivalents and marketable securities compared to $168.1 million as of December
31, 2014. Net cash used in operating activities for 2015 was $126.1 million,
compared to $67.0 million for 2014. The factors contributing to the change in
operating cash usage were primarily due to increased costs relating to our RSV
F Vaccine and higher employee-related expenses, as well as the timing of
customer and vendor payments. Subsequent to year-end 2015, Novavax completed
its offering of Convertible Senior Notes mentioned above.

Conference Call

Novavax management will host its quarterly conference call today at 8:00 a.m.
EST. The dial-in number for the conference call is (877) 212-6076 (Domestic) or
(707) 287-9331 (International), passcode 45346424. A webcast of the conference
call can also be accessed via a link on the home page of the Novavax website
(novavax.com) or through the "Investor Info"/"Events" tab on the Novavax
website.

A replay of the conference call will be available starting at 11:00 a.m. on
February 29, 2016 until midnight March 7, 2016. To access the replay by
telephone, dial (855) 859-2056 (Domestic) or (404) 537-3406 (International) and
use passcode 45346424. The replay will also be available as a webcast and can
be found on the "Investor Info"/"Events" on the Novavax website.

About Novavax

Novavax, Inc. (Nasdaq:NVAX) is a clinical-stage vaccine company committed to
delivering novel products to prevent a broad range of infectious diseases. Our
recombinant nanoparticles and Matrix-M™ adjuvant technology are the foundation
for groundbreaking innovation that improves global health through safe and
effective vaccines. Additional information about Novavax is available on the
Company's website,novavax.com.

Forward-Looking Statements

Statements herein relating to the future of Novavax and the ongoing development
of its vaccine and adjuvant products are forward-looking statements. Novavax
cautions that these forward looking statements are subject to numerous risks
and uncertainties, which could cause actual results to differ materially from
those expressed or implied by such statements. These risks and uncertainties
include those identified under the heading “Risk Factors” in the Novavax Annual
Report on Form 10-K for the year ended December 31, 2015 to be filed with the
Securities and Exchange Commission (SEC). We caution investors not to place
considerable reliance on the forward-looking statements contained in this press
release. You are encouraged to read our filings with the SEC, available at
sec.gov, for a discussion of these and other risks and uncertainties. The
forward-looking statements in this press release speak only as of the date of
this document, and we undertake no obligation to update or revise any of the
statements. Our business is subject to substantial risks and uncertainties,
including those referenced above. Investors, potential investors, and others
should give careful consideration to these risks and uncertainties.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share information)

Three Months Ended Twelve Months Ended
December 31, December 31,
2015 2014 2015 2014
------------------------------------------------------------
(unaudited)
Revenue $ 5,853 $ 6,724 $ 36,250 $ 30,659

Expenses:
Research and 75,903 33,332 162,644 94,422
development
General and 8,852 5,056 30,842 19,928
administrative
Total 84,755 38,388 193,486 114,350
expenses
Loss from (78,902 ) (31,664 ) (157,236 ) (83,691 )
operations
Interest income 95 118 419 129
(expense), net
Other income 1 ? (120 ) ?
(expense)
Realized gains on ? ? ? 615
marketable
securities
Net loss $ (78,806 ) $ (31,546 ) $ (156,937 ) $ (82,947 )
...

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